Gardasil

Gardasil is a vaccine developed by Merck, which states that it is a "vaccine that may help guard against diseases that are caused by human papillomavirus (HPV) Types 6, 11, 16, and 18." 

Clinical Trials
On its website, Merck states that in the clinical trials, adverse experiences - including pain, swelling, erythema, fever, nausea, pruritus, and dizziness - were recorded at 1% and higher than for those on the placebo. 

"Pushing for Mandatory HPV Vaccination"
Merck & Co.'s Gardasil (web), a new vaccine which "guards against strains" of the human papillomavirus (HPV) that "cause most cases of cervical cancer", was approved in June 2006 by the U.S. Food and Drug Administration. "An FDA advisory panel recommended that all girls get the vaccine at ages 11 or 12, before they are sexually active," the Associated Press reported January 31, 2007. "Currently, at least 18 states are debating whether to make the vaccine mandatory for schoolgirls."

Merck is "helping finance campaigns to get states to pass legislation that would make it mandatory for girls as young as 11 or 12 to receive" the vaccine and has "given money to Women in Government, an advocacy group that includes female state legislators throughout the United States. Many of the state bills advocating the use of Gardasil have been introduced by members of Women in Government, the AP reported.

"Some parents'-rights and conservative groups charge that Merck is engaging in underhanded lobbying ... [and] say making the vaccine mandatory would encourage premarital sex and interfere with how parents raise their children. "But Merck said it has been open about the fact that it provides funding to Women in Government," according to the AP.

In late February 2007, Merck announced that it would stop "lobbying state legislatures to require the use of its new cervical cancer vaccine." But some lobbying will continue, according to the medical affairs director of Merck's vaccine division, Dr. Richard M. Haupt. Merck will "continue to provide health officials and legislators with education about the vaccine and would continue to lobby for more financing for vaccines in general," he told the New York Times, adding:
 * "Our goal is to prevent cervical cancer. Our goal is to reach as many females as possible. Right now, school requirements and Merck’s involvement in that are being viewed as a distraction to that goal."

HPV Legislation at the State Level
In early March 2007, Virginia Governor Timothy M. Kaine said "he would sign legislation requiring all sixth-grade girls to be vaccinated against the sexually transmitted virus that can cause cervical cancer," reported Associated Press. 

The previous month, Texas Governor Rick Perry had "issued an executive order that made Texas the first state to require girls entering the sixth grade to receive the HPV [human papilloma virus] vaccine, beginning in September 2008." 

Some questioned why Perry, a social conservative, would be so eager to mandate a new and controversial vaccine for a sexually-transmitted disease. "One of [Merck]’s three lobbyists in Texas is Mike Toomey, Perry’s former chief of staff," reported Associated Press. Perry "also received $6,000 from Merck’s political action committee during his re-election campaign." 


 * HPV legislation in Alabama
 * HPV legislation in Alaska
 * HPV legislation in American Samoa
 * HPV legislation in Arizona
 * HPV legislation in Arkansas
 * HPV legislation in California
 * HPV legislation in Colorado
 * HPV legislation in Connecticut
 * HPV legislation in Delaware
 * HPV legislation in District of Columbia
 * HPV legislation in Florida
 * HPV legislation in Georgia
 * HPV legislation in Guam
 * HPV legislation in Hawaii
 * HPV legislation in Idaho
 * HPV legislation in Illinois
 * HPV legislation in Indiana
 * HPV legislation in Iowa
 * HPV legislation in Kansas
 * HPV legislation in Kentucky
 * HPV legislation in Louisiana
 * HPV legislation in Maine
 * HPV legislation in Maryland
 * HPV legislation in Massachusetts
 * HPV legislation in Michigan
 * HPV legislation in Minnesota
 * HPV legislation in Mississippi
 * HPV legislation in Missouri
 * HPV legislation in Montana
 * HPV legislation in Nebraska
 * HPV legislation in Nevada
 * HPV legislation in New Hampshire
 * HPV legislation in New Jersey
 * HPV legislation in New Mexico
 * HPV legislation in New York
 * HPV legislation in North Carolina
 * HPV legislation in North Dakota
 * HPV legislation in Northern Marianas Islands
 * HPV legislation in Ohio
 * HPV legislation in Oklahoma
 * HPV legislation in Oregon
 * HPV legislation in Pennsylvania
 * HPV legislation in Puerto Rico
 * HPV legislation in Rhode Island
 * HPV legislation in South Carolina
 * HPV legislation in South Dakota
 * HPV legislation in Tennessee
 * HPV legislation in Texas
 * HPV legislation in Utah
 * HPV legislation in Vermont
 * HPV legislation in Virginia
 * HPV legislation in Virgin Islands
 * HPV legislation in Washington
 * HPV legislation in West Virginia
 * HPV legislation in Wisconsin
 * HPV legislation in Wyoming

Contact Details

 * Company Website: http://www.gardasil.com/

Other Websites

 * GardasilWatch.com website (last updated September 2005).
 * Centers for Disease Control, Human Papillomavirus (HPV) Infection website

Gardasil Related Articles

 * Australian Cervical Cancer Foundation
 * Edelman
 * GCI
 * The Marketing of Gardasil in Australia
 * The Marketing of Gardasil in Canada
 * The Marketing of Gardasil in Europe
 * The Marketing of Gardasil in New Zealand
 * The Marketing of Gardasil in the United States

Other Related Articles

 * Direct-to-consumer advertising
 * Disease Mongering
 * Drug industry
 * Patient Groups

US Food and Drug Administration and other Agencies on Gardasil

 * U.S. Food and Drug Administration, "FDA Licenses New Vaccine for Prevention of Cervical Cancer: and Other Diseases in Females Caused by Human Papillomavirus: Rapid Approval Marks Major Advancement in Public Health", Media Release, June 8, 2006.
 * U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, "Product Approval Information - Licensing Action: Gardasil", accessed March 2007.
 * U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, "Product Approval Information - Licensing Action: GARDASIL® Questions and Answers", June 8, 2006.
 * U.S. Food and Drug Administration, "Take Time to Care: HPV (human papillomavirus)", Fact Sheet, June 2006.

Merck Product Information

 * Merck, "GARDASIL® Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine", Prescribing Information, October 2006.
 * Merck, "Patient Information about GARDASIL®", October 2006.

Merck Media Releases

 * Merck, "Merck's investigational vaccine GARDASILTM prevented 100 per cent of cervical pre-cancers and non-invasive cervical cancers associated with HPV types 16 and 18 in new clinical study, Media Release, October 6, 2005.
 * Merck, "Merck Submits Biologics License Application to FDA for GARDASIL®, the Company's Investigational Vaccine for Cervical Cancer", Media Release, December 5, 2005.
 * Merck, "European Commission Approves GARDASIL®, Merck's Cervical Cancer Vaccine", Media Release, September 22, 2006.
 * Merck, "Merck's Cervical Cancer Cavvine, Gardasil®, Added to the CDC Vaccines for Children, Media Release November 1, 2006.
 * Merck, "Merck Launches National Advertising Campaign for GARDASIL®, Merck's New Cervical Cancer Vaccine", Media Release, November 13, 2006.

Discussion in Medical Journals

 * Catherine M Lowndes and Noel Gill, "Cervical cancer, human papillomavirus, and vaccination: Vaccines work, but we need more information before widespread immunisation", British Medical Journal, October 22, 2005.
 * Rebecca Coombes, "Human papillomavirus vaccine: Life saving treatment or giant experiment?", British Medical Journal, April 7, 2007. (Sub req'd).

General Articles

 * "HPV vaccine: What you need to know" from the U.S. Centers for Disease Control and Prevention
 * Canadian Women's Health Network, "Sexually Transmitted Infections: Gardasil: What you need to know about the HPV vaccine: Pap tests still the best tool in preventing cervical cancer", Our Bodies Our Selves, accessed April 2007.
 * Gardasil Wikipedia article
 * Jacqueline Maley, "Cancer vaccine for girls before sex life starts", Sydney Morning Herald, July 16, 2005.
 * Maryann Napoli, "New Cervical Cancer Vaccine Should Not Be Mandatory", Center for Medical Consumers, December 2006.
 * "Drugmakers Hurry Sales, Delay Safety Studies--Gardasil," Alliance for Human Research Protection, February 9, 2007.
 * Brenda Wilson, "States Consider Requiring HPV Vaccine for Girls," All Things Considered/NPR, February 5, 2007.
 * Maryann Napoli, "How Vaccine Policy Is Made: The Story of Merck and Gardasil, the HPV Vaccine", Center for Medical Consumers, March 2007.
 * John Carreyrou, "Viral Marketing: Questions on Efficacy Cloud a Cancer Vaccine: Merck Predicts Big Fall In Cervical Lesions, But Data Are Complex", Wall Street Journal, April 16, 2007; Page A1. (Sub req'd).
 * "To market a drug: Financing a vaccine against cervical cancer may be the right thing to do, but a multinational giant's aggressive campaign has muddied the debate," The Vancouver Sun, CanWest News Service (Canada), May 14, 2007.
 * Judith Siers-Poisson, The Politics and PR of Cervical Cancer, a four part series, PRWatch.org, July, 2007.
 * WHALE